Health Law Advisor

On October 23, 2024, Dr. Jill Biden, first lady of the United States,  announced the winners of $110 million in awards on behalf of the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative research and development in women’s health.

“It’s time for investors, researchers, and business leaders to have [conversations about women’s health], not as an afterthought but as a first thought,” Dr. Biden said in her prepared remarks. “Those kinds of questions belong in your research proposals, in your laboratories, in your pitch decks.”

The awards will go to 23 teams from small startups to global innovators working to further developments in women’s health—with projects ranging from a non-invasive blood test to diagnose endometriosis to a revolutionary treatment for late-stage and metastatic ovarian cancer.

On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the Medicare program will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305).

The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. Instead, CMS chose an alternate pathway known as Coverage with Evidence Development (“CED”).  If the proposal is adopted by CMS, it would set in motion a detailed regulatory process that includes temporary Medicare coverage for the drug but only for certain Medicare beneficiaries who are enrolled in an additional clinical trial intended to test whether these drugs will have a significant benefit for Medicare beneficiaries.  CMS expects to issue a decision by April 11, 2022 to approve or reject the CED process after reviewing comments from interested parties.